Committee on the Safety of Medicines

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Committee on the Safety of Medicines
AbbreviationCSM
SuccessorMedicines and Healthcare products Regulatory Agency (MHRA)
Formation1970
Dissolved2005
TypeAdvisory body
HeadquartersLondon, United Kingdom
Region served
United Kingdom
Parent organization
Department of Health and Social Care


The Committee on the Safety of Medicines (CSM) was an independent advisory committee established in the United Kingdom in 1970. Its primary role was to provide advice to the government on the safety, quality, and efficacy of medicines. The CSM played a crucial role in the regulation of pharmaceuticals, ensuring that medicines available to the public were safe and effective.

History[edit | edit source]

The CSM was formed in response to the thalidomide tragedy of the late 1950s and early 1960s, which highlighted the need for more rigorous drug safety regulations. The committee was part of a broader effort to improve drug safety and restore public confidence in the pharmaceutical industry.

Functions[edit | edit source]

The CSM was responsible for:

  • Evaluating the safety and efficacy of new medicines before they were marketed.
  • Monitoring the safety of medicines already on the market through pharmacovigilance activities.
  • Advising on the withdrawal of medicines that posed unacceptable risks to patients.
  • Providing guidance on the safe use of medicines to healthcare professionals and the public.

Structure[edit | edit source]

The committee was composed of experts in various fields, including pharmacology, medicine, and pharmacy. Members were appointed by the Department of Health and Social Care and served on a part-time basis. The CSM worked closely with the Medicines Control Agency (MCA), which was responsible for the day-to-day regulation of medicines.

Dissolution and Legacy[edit | edit source]

In 2005, the CSM was dissolved and its functions were absorbed by the newly formed Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA continues to uphold the principles of drug safety and efficacy that were central to the CSM's mission.

Impact[edit | edit source]

The CSM was instrumental in shaping the regulatory landscape for medicines in the UK. Its work helped to establish rigorous standards for drug approval and monitoring, which have been adopted by other regulatory bodies worldwide.

Also see[edit | edit source]

Template:Regulation of medical devices



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Contributors: Prab R. Tumpati, MD